|Contract Covers Development of Cell-Based Influenza Vaccines and Planning for a U.S. Manufacturing Facility|
Solvay Pharmaceuticals announced today that it was awarded a $298 million, five-year contract from the United States Department of Health and Human Services (HHS) to develop cell-based influenza vaccines and plan for domestic manufacturing capacity in the U.S.
The milestone-based contract, awarded to Solvay Pharmaceuticals in the U.S., covers the development and testing of new influenza vaccines including pandemic vaccines that are produced using cell-based technology and the development of a master plan to manufacture, formulate, fill and package annual and pandemic influenza vaccines in a new U.S.-based facility. Other activities that will be supported by the award include the submission of an Investigational New Drug (IND) application, pre-clinical and clinical studies for seasonal and pandemic-like vaccines, adjuvant development and a Biologics License Application (BLA) allowing for the distribution and marketing of influenza vaccines in the U.S. The award also includes funding to support development and design costs associated with establishing a new U.S.-based influenza vaccine manufacturing facility.
"Cell-based influenza vaccines can play an important role in pandemic preparedness and provide an alternative to existing technologies designed to prevent the seasonal flu," said Werner Cautreels, Ph.D., CEO of Solvay Pharmaceuticals. "Solvay Pharmaceuticals' 50-year heritage in the influenza vaccine business and 15 years of experience in researching and developing cell-based influenza vaccines uniquely position us to fulfill the requirements of this contract."
"Our expertise gained from building our new commercial scale, cell-based influenza vaccine manufacturing facility in The Netherlands provides a strong foundation for the development of a similar facility in the U.S." said Cautreels. "We look forward to working closely with the U.S. government to ensure access to our influenza vaccine technology for the American public."
Solvay Pharmaceuticals, Inc., of Marietta, Georgia is the U.S. subsidiary of Solvay Pharmaceuticals. For more information, visit www.solvaypharmaceuticals-us.com.
Solvay Pharmaceuticals is a research driven group of companies that constitute the global pharmaceutical business of the Solvay Group. The company seeks to fulfill carefully selected, unmet medical needs in the therapeutic areas of neuroscience, cardio-metabolic, influenza vaccines, gastroenterology, specialized markets and men's and women's health. Its 2005 sales were EUR 2.3 billion and it employs approximately 10 000 people worldwide. For more information, visit www.solvaypharmaceuticals.com.
Solvay is an international chemicals and pharmaceuticals group with headquarters in Brussels. It operates in more than 50 countries, with some 30,000 employees. In 2005 its consolidated sales amounted to EUR 8.6 billion, generated by its three sectors of activity: Chemicals, Plastics and Pharmaceuticals. Solvay SA is listed on the Euronext 100 index of top European companies. Details are available at www.solvay.com.
NOTES TO THE EDITOR
Solvay Pharmaceuticals was the first influenza vaccine provider in the world to receive approval from a regulatory authority for continuous cell line technology used in the prevention of influenza. This cell-based vaccine was licensed by the Dutch authorities in 2001. This new technology adds flexibility and efficiency to the current production method using a continuous cell line rather than chicken eggs. This provides better control of product quality and increased responsiveness (surge capacity), in the event of an influenza pandemic. Furthermore, this state-of-the-art production technology is not dependent on chicken egg supply logistics or the ability of the virus to sufficiently grow in chicken eggs. The goal of the contract award is to generate the capability in the U.S. to produce at least 150 million doses of pandemic vaccine within six months of the start of a pandemic.
As part of this award, the company will plan for the establishment of a state-of-the-art cell-based vaccine facility in the U.S. using experience gained in constructing and validating its new biosafety level 3 cell culture manufacturing, filling and packaging facilities in The Netherlands.
In June 2005, the company announced it had submitted a master file (MF) to the U.S. Food and Drug Administration (FDA) for its cell-derived influenza vaccine. On November 16, 2005, the company also presented an overview of its development of its cell-based production process to the FDA Vaccines and Related Biologics Advisory Committee. The company plans to file an IND later this year and will initiate human clinical trials using commercial scale vaccine from its state-of-the-art cell-based vaccine facility in The Netherlands.
Solvay Pharmaceuticals has been a major worldwide supplier of influenza vaccines since the late 1940s and is an innovator in this area. The European-based Business Group Influenza unit of Solvay Pharmaceuticals currently manufactures and markets an egg-derived influenza vaccine in 58 countries worldwide; however, this product is not approved for use in the U.S.
Photos of the company's new cell-based vaccine facility in The Netherlands are available upon request.